Celgene Corporation (NASDAQ: CELG) today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The application requests authorization to manufacture and market generic versions of REVLIMID® (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.
Celgene intends to vigorously enforce its extensive intellectual property rights for REVLIMID and plans to file a complaint alleging infringement within the required 45-day response period. REVLIMID is currently protected by 12 issued patents listed in the FDA's Approved Drug Products List (Orange Book) and has additional patent applications pending. The issued patents comprise composition of matter, polymorph and method of use claims as well as claims related to Celgene's proprietary RevAssist® system. In order for Natco to avoid liability, all patent claims in the suit must be deemed invalid, not infringed, unenforceable, or expired.